Using low doses of epirubicin to treat sepsis and septic shock
Epirubicin for the Treatment of Sepsis & Septic Shock
This study is testing if low doses of a cancer drug called epirubicin can help people with sepsis and septic shock recover better and survive longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Jena, Thuringia and 4 other locations) |
| Trial ID | NCT05033808 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of low doses of epirubicin in patients with sepsis and septic shock. It aims to determine whether low-dose epirubicin can induce tolerance to infection and improve organ function, potentially leading to better survival rates. The trial will be conducted as a dose-escalation study, where patients will receive varying doses of epirubicin or a placebo, with careful monitoring for side effects. The hypothesis is based on previous animal studies that showed increased survival with low-dose epirubicin treatment.
Who should consider this trial
Good fit: Ideal candidates are ICU patients diagnosed with sepsis or septic shock within the last 24 hours.
Not a fit: Patients with certain blood disorders, active cancer, or severe cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve outcomes for patients suffering from sepsis.
How similar studies have performed: While the approach of using low-dose epirubicin is novel, previous studies in animals have shown promising results in enhancing survival during infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * admitted to the ICU with sepsis or septic shock, diagnosed within the previous 24 hours Exclusion Criteria: * Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leucocyte Count \<4000/μL; Neutrophile/ platelets Count below Lower Limit of Normal). * Weight \>135 kg/BMI \>45. * Active neoplasia. * History of chemotherapy. * Hypersensitivity to epirubicin * History of bone marrow or solid organ transplantation. * Immunosuppressive therapy. * Acute severe infection within 4 weeks prior to admission (Hospitalization or admission to higher level clinical care facility for infection). * Chronic infection. * Cardiomyopathy with a documented ejection fraction \<30% or AICD (automatic internal cardioverter defibrillator) implantation. * Acute liver failure following the European Association for the Study of the Liver definition as International Normalized Ratio (INR) \>1.5 and elevation of transaminases \> 3 times of the upper normal limit (2). * Pregnancy during all trimesters/breast-feeding. * Chronic mechanical ventilation dependency. * Cystic fibrosis. * Concomitant medication with Verapamil or Cimetidine. * Prior enrollment in this study. * Participation in another clinical intervention trial.
Where this trial is running
Jena, Thuringia and 4 other locations
- Jena University Hospital — Jena, Thuringia, Germany (Recruiting)
- University Hospital Knappschafstkrankenhaus Bochum — Bochum, Germany (Not_yet_recruiting)
- University Medicine Greifswald — Greifswald, Germany (Not_yet_recruiting)
- Universitätsklinikum Hamburg Eppendorf — Hamburg, Germany (Not_yet_recruiting)
- Universitätsklinikum Würzburg — Würzburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Sebastian Weis, M.D. — Jena University Hospital
- Study coordinator: Sebastian Weis, M.D.
- Email: Sebastian.Weis@med.uni-jena.de
- Phone: +49 (0) 3641-932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.